Rapidly eroding anchor

ABSTRACT

An anchor for using a closure device includes a body being configured to move from a pre-deployed state to a deployed state. In the pre-deployed state, the body has a first width aspect relative to a direction of deployment and a second width aspect in the deployed state relative to the direction of deployment, the second width aspect being greater than the first width aspect and wherein the body is formed from a rapidly eroding material configured to erode through dissolution within a body lumen.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application claims the benefit of and priority to U.S.Provisional Patent Application Ser. No. 61/143,751, entitled “VesselClosure Devices and Methods,” filed Jan. 9, 2009, the disclosure ofwhich is incorporated herein by reference in its entirety.

BACKGROUND

1. Technical Field

The present disclosure relates generally to medical devices and theirmethods of use. In particular, the present disclosure relates to vesselclosure systems and devices and corresponding methods of use.

2. The Technology

Catheterization and interventional procedures, such as angioplasty orstenting, generally are performed by inserting a hollow needle through apatient's skin and tissue into the vascular system. A guidewire may beadvanced through the needle and into the patient's blood vessel accessedby the needle. The needle is then removed, enabling an introducer sheathto be advanced over the guidewire into the vessel, e g in conjunctionwith or subsequent to a dilator.

A catheter or other device may then be advanced through a lumen of theintroducer sheath and over the guidewire into a position for performinga medical procedure. Thus, the introducer sheath may facilitateintroducing various devices into the vessel, while minimizing trauma tothe vessel wall and/or minimizing blood loss during a procedure.

Upon completing the procedure, the devices and introducer sheath wouldbe removed, leaving a puncture site in the vessel wall. Traditionally,external pressure would be applied to the puncture site until clottingand wound sealing occur. However, the patient must remain bedridden fora substantial period after clotting to ensure closure of the wound. Thisprocedure may be time consuming and expensive, requiring as much as anhour of a physician's or nurse's time. It is also uncomfortable for thepatient and requires that the patient remain immobilized in theoperating room, catheter lab, or holding area. In addition, a risk ofhematoma exists from bleeding before hemostasis occurs.

BRIEF SUMMARY

An anchor for using a closure device may include a body being configuredto move from a pre-deployed state to a deployed state. In thepre-deployed state, the body has a first width aspect relative to adirection of deployment and a second width aspect in the deployed staterelative to the direction of deployment, the second width aspect beinggreater than the first width aspect and wherein the body is formed froma rapidly eroding material configured to erode through dissolutionwithin a body lumen.

A method of closing a puncture in a wall of a body lumen may includeadvancing an anchor in a deployment direction through the anchor, theanchor having a first width aspect relative to the deployment direction,deploying the anchor distally of the wall of the body lumen to cause theanchor to move to have a second width aspect relative to the deploymentdirection, the second width aspect being larger than the first widthaspect, drawing the anchor distally into engagement with a distal sideof the wall of the body lumen, and deploying a closure element into thewall of the body lumen, wherein the anchor is formed from a rapidlyeroding material that dissolves in the body lumen in less than twelvehours.

A closure device system may include a delivery sheath, a rapidly erodinganchor at least partially disposed within the delivery sheath in aninitial configuration, the closure member comprising one or more sugars,a suture element coupled to the closure member and disposed at leastpartially through the delivery sheath, and a pusher disposed at leastpartially within the delivery sheath and configured to deploy the anchormember from a distal end of the delivery sheath.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and are intended toprovide further explanation of the invention claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features of thepresent disclosure, a more particular description of the disclosure willbe rendered by reference to specific embodiments thereof which areillustrated in the appended drawings. It is appreciated that thesedrawings depict only illustrated embodiments of the disclosure and aretherefore not to be considered limiting of its scope. The disclosurewill be described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIGS. 1A-1C illustrate a closure device in which a rapidly erodinganchor can be implemented according to one example;

FIGS. 1D-1F illustrate a method of closing a puncture in a wall of abody lumen in which a rapidly eroding anchor can be implemented;

FIGS. 2A-2E illustrate a closure device and a method for closing apuncture in a wall of a body lumen in which a rapidly eroding anchor canbe implemented according to one example; and

FIG. 3 illustrates a closure device and a method for closing a puncturein a wall of a body lumen in which a rapidly eroding anchor can beimplemented according to one example.

DETAILED DESCRIPTION

The present disclosure relates to devices, systems, and methods forclosing an opening in a body lumen. For example, the present disclosureincludes an anchor, such as an intra-arterial “foot,” comprising arapidly eroding material. The anchor may be passed through an openingdefined in a wall of a body lumen and deployed. The anchor can then bedrawn proximally to draw the anchor into contact with a distal side ofthe body lumen wall. A closure element can then be deployed to close thepuncture.

In at least one example, once deployed within a body lumen, the anchormay dissolve in less than a day or even less than an hour as desired.The rapid erosion of the anchor can allow the anchor to be left in placeafter the closure element has been deployed by obviating the need forremoval of the anchor. By leaving the anchor in place until itdissolves, damage that may occur by drawing the anchor through theclosed puncture and/or the deployed closure element can be reduced oreliminated.

In addition, the erosion time of the anchor may fall within the timeframe of the action of an anti-thrombotic medication being used inconjunction with the treatment of a patient. Accordingly, the closureelement of the present disclosure may reduce the risk of formation ofintra-arterial clots associated with the closure of the body lumenopening.

Reference is now made to FIG. 1A, which illustrates a closure device 100according to one example. As shown in FIG. 1A, the closure device 100may include a delivery sheath 110 and a pusher 120 that are configuredto cooperate to deploy an anchor 130, such as an intra-arterial foot,and a closure element 140, such as a plug, and a suture element 150. Inat least one example, the delivery sheath 110 is configured to house theanchor 130 and the closure element 140 while the pusher 120 isconfigured to deploy the anchor 130 and/or the closure element 140 fromthe delivery sheath 110. The exemplary delivery sheath 110, pusher 120,anchor 130, and closure element 140 of FIG. 1A will be discussed in moredetail with reference to FIG. 1B.

FIG. 1B illustrates an exploded view of the closure device 100. As shownin FIG. 1B, the delivery sheath 110 includes an outer housing 112 and agrip portion 114 while the pusher 120 includes a handle portion 122 anda shaft portion 124. An interior lumen 116 is defined in the outerhousing 112 that is configured to receive the pusher 120 in such amanner as to allow the pusher 120 to be extended from and retractedwithin a distal end 112A of the outer housing 112. For example, theinterior lumen 116 can include a first portion 116A configured toreceive the shaft portion 124 of the pusher 120 while a second portion116B of the interior lumen 116 can be configured to receive a distal end124A of the shaft portion 124.

More specifically, the second portion 116B of the interior lumen 116 mayhave a larger width aspect than the width aspect of the first portion116A. The width aspects of the first portion 116A and the second portion116B can be the diameters thereof or other cross sectional profiles thatare generally transverse to a center axis C of the delivery sheath 110.For ease of reference, the center axis C of the delivery sheath 110 willbe referenced in describing the position and movement of the othercomponents described herein. In the illustrated example, the interiorlumen 116 may transition from the smaller diameter of the first portion116A to a second larger diameter of the second portion 116B at ashoulder 118.

Such a configuration can allow the pusher 120 to translate axiallyrelative to the delivery sheath 110 within a desired range of motion. Inparticular, the handle portion 122 can translate within the secondportion 116B of the interior lumen 116 to advance the shaft portion 124within the outer housing 112 to thereby move the distal end 124A of theshaft portion 124 relative to the distal end 112A of the outer housing112. Interaction between the handle portion 122 and the shoulder 118 canhelp ensure the distal end 124A does not extend beyond a desiredposition within the outer housing 112.

In the illustrated example, the first portion 116A may also beconfigured to receive the anchor 130 and the closure element 140proximally of the distal end 124A of the shaft portion 124. Accordingly,as the distal end 124A of the shaft portion 124 is advanced toward thedistal end 112A of the outer housing 112, the distal end 124A of theshaft portion 124 can engage the anchor 130 and/or the closure element140 to move the anchor 130 and/or the closure element 140 distally fromthe outer housing 112.

The anchor 130 can be configured to move from a pre-deployed statehaving a pre-deployed width aspect to a deployed state having a deployedwidth aspect. The deployed width aspect may be greater than thepre-deployed width aspect. The anchor 130 can have any configurationthat allows for this. In the illustrated example, anchor 130 isconfigured to rotate or be rotated between the pre-deployed state andthe deployed state. In other examples, the anchor 130 may be configuredto unfold from a configuration have a pre-deployed width aspect to adeployed state having a greater width aspect. For example, one or morearms may be configured to unfold and fold about a plurality of pivot orhinge points.

As shown in FIG. 1B, the anchor 130 includes leg members 132, 134 thatdefine a major axis 136 of the anchor 130. The anchor 130 can furtherinclude an eyelet 138 coupled to one or both of the leg members 132,134. The eyelet 138 can be located at a position that causes the anchor130 to rotate when a force acting initially parallel to the major axis136 is exerted on the eyelet 138. Such a configuration can allow theanchor 130 to move from a state in which the major axis 136 is alignedwith the central axis C to a state in which the major axis 136 isoriented more obliquely to the central axis C, such as generallyperpendicular to the central axis C.

This rotation can be accomplished by applying a distally acting force onthe anchor 130 to move the anchor 130 out of the outer housing 112 andthen a proximally directed force to the anchor 130 by way of the eyelet138. In at least one example, the distally acting force applied to theanchor 130 can be provided from the pusher 120 by way of the closureelement 140 while the proximally directed force can be applied by way ofthe suture element 150. The anchor 130 can thus be used to position theclosure device 100 for deployment of the closure element 140.

In one embodiment, the closure element 140 may be configured to close anopening in a lumen as well as at least partially obstruct a tissue tractleading from an external surface of the tissue to the lumen. The shapeof the closure element 140 may be configured to be housed within thefirst portion 116A of the interior lumen 116. For example, the closureelement 140 may conform to the shape of the interior lumen 116. In oneembodiment, the closure element 140 may be cylindrical in shape prior tobeing deployed from the delivery sheath 110. Once deployed from thedelivery sheath 110, the closure element 140 may be deformable toconform to any desired shape to close an opening in a body lumen and/orthe tissue tract leading to the lumen opening.

As shown, the example pusher 120 can be coupled to the closure element140 and/or anchor 130 by way of the suture element 150. In particular,the suture element 150 can loop through the anchor 130 such that thesuture element 150 has two free ends that pass through or near theclosure element 140, and extend proximally into or beyond the handleportion 122 of the pusher 120. In at least one example, the free ends ofthe suture element 150 pass through separate portions or channels of theclosure element 140. In one embodiment, the pusher 120 can have a suturelumen 126 defined therein that extends through the shaft portion 124 andextends proximally to or even through the handle portion 122. The sutureelement 150 can be extended from the closure element 140 and into thepusher 120 by way of the suture lumen 126.

In one embodiment, the delivery sheath 110 may include a guidewire lumen160 with a proximal guidewire port 162 therein near the proximal end112B of the outer housing 112 and a distal guidewire port 164 near thedistal end 112A of the outer housing 112. The guidewire lumen 160 may beat least partially integrated or entirely distinct from the interiorlumen 116 of the delivery sheath 110. Accordingly, a guidewire can enterthe proximal guidewire port 162, pass through the guidewire lumen 160,and exit the distal guidewire port 164. As a result, the example closuredevice 100 can advance over a guidewire and into position with a lumenopening as part of a method to close the lumen opening. One such methodwill now be discussed in more detail with reference to FIGS. 1C-1F.

Reference is now made to FIG. 1C, which illustrates a step in theprocess of deploying the anchor 130. As shown in FIG. 1C, the deliverysheath 110 can be positioned to move the distal end 112A of the outerhousing 112 through a tract 170 defined in tissue 172 and into proximitywith a lumen 174 and a puncture 176 defined in a lumen wall 178 inparticular.

Thereafter, as shown in FIG. 1D, the pusher 120 can be manipulated asdescribed above to cause the anchor 130 to be pushed out of the distalend 112A of the outer housing 112. For example, the pusher 120 may pushthe closure element 140 which may, in turn, push the anchor 130 distallyrelative to the outer housing 112, thereby deploying the anchor 130 fromthe distal end 112A of the outer housing 112. In one embodiment, oncedeployed, the anchor 130 may rotate or be rotated from a firstorientation, in which the major axis 136 of the anchor 130 is at a smallangle or generally parallel with the outer housing 112 and generallyperpendicular to the lumen wall 178 as shown in FIG. 1C, to a secondorientation in which the major axis 136 of the anchor 130 is generallyparallel with the lumen 170 and at a greater angle or generallyperpendicular to the delivery sheath 110 as shown in FIG. 1D.

In particular, as shown in FIG. 1D, once the anchor 130 is pushed fromthe distal end 112A of the outer housing 112, the anchor 130 may rotateor be rotated to the second orientation, such as by tension applied toby the suture element 150 to the anchor 130 by way of the eyelet 138.The anchor 130 can then be drawn in the proximal direction to secure theanchor 130 against a distal surface 178A of the lumen wall 178. Theanchor 130 may comprise any of a number of different materials. In oneexample, the anchor 130 may comprise a bioabsorbable material. In afurther embodiment, the anchor 130 may comprise a rapidly erodingmaterial as disclosed in more detail herein.

As also shown in FIG. 1D, the anchor 130 can be used to stabilize tissuearound the puncture 176 in order to facilitate closure of the puncture176. In particular, once the anchor 130 is deployed, the anchor 130 maythen be secured against a distal side 178A of the lumen wall 178 bypulling the suture element 150, which is coupled to the anchor 130,proximally. In one example, a suture lock (not shown) can be utilized tohelp maintain the tension in the suture element 150. Once the anchor 130is secured against the distal side 178A of the lumen wall 178, the outerhousing 112 may be advanced distally. In particular, the outer housing112 can be advanced to exert a force against a proximal side 178B of thelumen wall 178. The combination of the forces exerted by the anchor 130and the outer housing 112 on the lumen wall 178 may result in acompressive force on the tissue near the puncture 176. As a result, thepuncture 176 may be compressed and/or located by the delivery sheath 110and the outer housing 112 in particular. This may allow an adjustablesandwiching and location of the lumen opening by the combination oftension in the suture element 150 and compression created by thedelivery sheath 110.

With the anchor 130 deployed, the pusher 120 may then deploy the closureelement 140 within the puncture 176 and/or the tract 170 near a proximalside 178B of the lumen wall 178. In particular, as shown in FIG. 1E thepusher 120 can be advanced distally, the delivery sheath 110 can bedrawn proximally, and/or some combination of such movements can be usedto move the closure element 140 distally out of the outer housing 112and into contact with the proximal side 178B of the lumen wall 178adjacent the puncture 176.

In such a step, the lumen wall 178 is positioned between the anchor 130and the closure element 140. Thus, the closure element 140 can bepositioned to reduce or stop the flow of fluid out of the tract 170 bycovering the puncture 176 and/or obstructing the tract 170.

In one embodiment, the pusher 120 remains in continuous contact with theclosure element 140 throughout the deployment process. Such aconfiguration can allow the anchor 130 and/or closure element 140 to bedeployed by advancing the pusher 120 in a single direction. Byfacilitating deployment of the anchor 130 and closure element 140 usingone-way movement of the pusher 120, and by utilizing a single pusher120, the closure device 100 may result in a quicker and easierdeployment of the anchor 130 and/or closure element 140.

The engagement of the anchor 130 and the closure element 140 to thelumen wall 178 may be secured in any desired manner. In at least oneexample, the free ends of the suture element 150 may pass from theanchor 130 through the closure element 140. In such an example, a suturelock and/or a knot pusher can be used to advance a knot into proximitywith the closure element 140 and tighten the knot to thereby maintaintension between the anchor 130 and the closure element 140. A suturecutter can then sever the suture element 150. A suture lock, a knotpusher, and/or a suture cutter can be advanced through a suture lumen126 defined in the pusher 120 either before or after the delivery sheath110 and the pusher 120 are withdrawn from the tract 170. As a result,the suture element anchor 130, closure element 140, and suture element150 can remain in the tissue tract 170 as shown in FIG. 1F.

As previously introduced, the anchor 130 can be formed of a rapidlyeroding material that allows the anchor 130 to be left in place withinthe lumen 174. The composition of the anchor 130 allows the anchor 130to remain in position for a long enough period to enable the closureprocedure and a short enough period to allow sufficient erosion of theanchor 130 while the patient is still under physician control or in thehospital. This time period can therefore be in a range of roughlybetween 30 minutes and 12 hours. The anchor 130 may be formed of amaterial that is strong enough to allow for secure anchoring of aclosure element, such as the plug and/or other closure elementsdescribed below.

Further, the anchor 130 may be formed of a material that isbiocompatible in an intravascular environment and non-thrombogenic. Ananchor with these characteristics may be obtained by using a mechanismof dissolution rather than chemical degradation. Rapidly dissolvingcompounds that are suitable include, but are not limited to, sugars andsugar-derivatives like sugar-alcohols. Representative examples aresugars like glucose, fructose, lactose, maltose, and sugar alcohols likemannitol, sorbitol and isomalt. Strength can be added to the formulationby including a polymeric component, such as poly-vinylpyrrolidone,poly-ethyleneglycol, or a polysaccharide like starch,hydroxyethylstarch, dextran or dextran sulfate. Sugar alcohols such asmannitol, sorbitol, and isomalt have relatively low melting points, andform good solvents for the polysaccharides. This can facilitatemanufacturing, since a simple melt process can be used. Various mixturesof these components are possible, resulting in potentially differentanchor properties. Hydroxyethyl starch has a relatively low glasstransition temperature, and so has a mannitol-sorbitol mixture. Asolution of hydroxyethyl starch in mannitol-sorbitol, when solidified,may have a glass transition below body temperature, which will create atough, but not brittle anchor. On the other end of the spectrum, amixture of dextran with isomalt has a much higher glass transition,resulting in a very hard and strong anchor, but with higher brittleness.Since all these components are miscible, a wide range of properties canbe achieved by mixing them in corresponding proportions to achieve thedesired properties.

In one embodiment, the rapidly eroding material can be configured to beat least partially porous and/or micro-porous. Accordingly, one or morebeneficial agents can be incorporated into at least one of the pores ofthe rapidly eroding material. For example, the beneficial agents mayinclude anti-clotting agents, such as heparin, anti-inflammatory agents,and/or other beneficial agents. One method for producing a porousrapidly eroding material may include freeze drying the rapidly erodingmaterial. In particular, in one example embodiment, acetic acid may beused as a solvent for freeze drying the rapidly eroding material.Polymers, such as PLGA, which are soluble in acetic acid, may be used aspart of the freeze-drying process.

In a further embodiment, a micro-porous silicon may be used. Inparticular, the micro-porous silicon may be prepared with variousdegradation rates, including rapidly degrading forms. The micro-poroussilicon may be sufficiently strong to be used in an anchor, such as abioerodible foot, and/or may also have sufficient porosity to allowincorporation of beneficial agents. For example, in one embodiment, itmay be desirable to incorporate a hydrophobic heparin derivative, suchas benzalkonium heparin, into the porosity of the anchor because of itslow solubility. The closure element 140 may comprise any number ofdifferent materials suitable for use as a plug.

FIG. 2A illustrates a closure device 200 in which an anchor 130′ similarto the anchor 130 described above may be implemented. In the illustratedexample, the closure device 200 can include a delivery sheath 110′having an outer housing 112′ and a grip portion 114′. An interior lumen116′ is defined in the outer housing 112′ configured to house the anchor130′. The closure device 200 further includes deployment assembly 210that includes a garage sheath 220 configured to house an actuator member230, which in turn can be configured to house a carrier tube 240, whichin turn is configured to house a pusher 120′.

The pusher 120′ can be configured to translate axially within thecarrier tube 240 to deploy the anchor 130′ from the closure device 200.A closure element 250 is configured to be positioned on the carrier tube240. As will be discussed in more detail below, distal movement of theactuator member 230 relative to the carrier tube 240 may deploy theclosure element 250.

In the illustrated example, the garage sheath 220 includes a housingportion 222 coupled to a plunger portion 224. The first plunger portion224 can be positioned proximally of the grip portion 114′ of thedelivery sheath 110. The actuator member 230 can include a housingportion 232 and a second plunger portion 234. The carrier tube 240 canalso include a housing portion 242 and a third plunger portion 244. Thepusher 120′ includes a handle portion 122′ and a shaft portion 124′.

As shown in FIG. 2B, the pusher 120′ can be used to deploy the anchor130′ from the delivery sheath 110′ using a suture element 150′ in asimilar manner as described above. Once the anchor 130′ is deployed, thefirst plunger portion 224 can be advanced proximally relative to thedelivery sheath 110′ along with the second plunger portion 234 and thethird plunger portion 244 to position the deployment assembly 210 inproximity with the lumen wall 178.

Thereafter, as shown in FIG. 2C, the first plunger portion 224 may bedrawn proximally toward the second plunger portion 234 and the thirdplunger portion 244, the second plunger portion 234 and the thirdplunger portion 244 may be advanced distally, and/or some combination ofthose movements may be performed to expose the actuator member 230 andthe carrier tube 240 from the garage sheath 220 while maintaining thecarrier tube 240 in engagement with the lumen wall 178. In such anexample, the delivery sheath 110′ can remain in place to maintain thelumen wall 178 between the delivery sheath 110′ and the anchor 130′.

As shown in FIG. 2D, the second plunger portion 234 can then be advanceddistally relative to the third plunger portion 244 to expand and deploythe closure element 250. In particular, as shown in FIG. 2D, the carriertube 240 includes ramped portions 246. As the second plunger portion 234advances distally relative to the third plunger portion 244, theactuator member 230 pushes the closure element 250 over the rampedportions 246 of the carrier tube, thereby expanding the closure element250. Thereafter, the closure device 200 can be removed and the sutureelement 250 cut as described above.

Continued advancement of the actuator member 230 distally relative tothe carrier tube 240 moves tissue-engaging portions 252 of the closureelement 250 into engagement with the lumen wall 178. Further distalmovement of the actuator member 230 pushes the closure element 250distally of the carrier tube 240. In at least one example, the closureelement 250 can be formed of a resilient material having a trained ordefault state having a narrow diameter. The closure element 250 can bepartially expanded onto the carrier tube 240 prior deployment. As theclosure element 250 moves distally from the carrier tube 240, theclosure element 250 can move toward the trained or default state,thereby closing the puncture 176.

As shown in FIG. 2E, once the closure element 250 is deployed, a plugmaterial 260 may be injected near the lumen wall and within the tract170. A suture element 150′ may be secured, such as by knotting, and thensevered, thereby leaving the anchor 130′, closure element 250, and plug260 in place while the remaining components of the closure device 200are retracted. Thereafter, the rapidly eroding material of the anchor130′ may then dissolve into the fluid flow within the lumen. In anotherexample, the anchor maybe dissolved soon after the procedure allowingthe suture element 250 to be removed and obviating the use of the plugmaterial 260. In still further examples, the anchor 130′ may be let godown stream by slipping off the suture from the anchor, thus leavingbehind only the closure element 250.

FIG. 3 illustrates a closure device 200′ configured for use as anover-the wire deployment that is similar to the closure device 200 shownin FIGS. 2A-2E. The closure device 250′ may be advanced over a guidewire300. In the example shown in FIG. 3, the delivery sheath 110′ and garagesheath 220 of FIGS. 2A-2E have been omitted. In such an example, theanchor 130′ can be housed within the carrier tube 240 and pusheddistally using a pusher 120′ translating therein. Thereafter, theclosure device 200′ can deploy the anchor 130′ and the closure element250 in a similar manner as described above with reference to FIGS. 2A-2Eby advancing an actuator member 230 relative to a carrier tube 240.

Embodiments of the closure element, the delivery sheath, and the likemay include a material made from any of a variety of known suitablebiocompatible materials, such as a biocompatible shape memory material(SMM). For example, the SMM may be shaped in a manner that allows for adelivery orientation while within the tube set, but may automaticallyretain the memory shape of the component once deployed into the tissueto close the opening. SMMs have a shape memory effect in which they maybe made to remember a particular shape. Once a shape has beenremembered, the SMM may be bent out of shape or deformed and thenreturned to its original shape by unloading from strain or heating.Typically, SMMs may be shape memory alloys (SMA) comprised of metalalloys, or shape memory plastics (SMP) comprised of polymers. Thematerials may also be referred to as being superelastic.

Usually, an SMA may have an initial shape that may then be configuredinto a memory shape by heating the SMA and conforming the SMA into thedesired memory shape. After the SMA is cooled, the desired memory shapemay be retained. This allows for the SMA to be bent, straightened,twisted, compacted, and placed into various contortions by theapplication of requisite forces; however, after the forces are released,the SMA may be capable of returning to the memory shape. The main typesof SMAs are as follows: copper-zinc-aluminum; copper-aluminum-nickel;nickel-titanium (NiTi) alloys known as nitinol; nickel-titaniumplatinum; nickel-titanium palladium; and cobalt-chromium-nickel alloysor cobalt-chromium-nickel-molybdenum alloys known as elgiloy alloys. Thetemperatures at which the SMA changes its crystallographic structure arecharacteristic of the alloy, and may be tuned by varying the elementalratios or by the conditions of manufacture. This may be used to tune thecomponent so that it reverts to the memory shape to close thearteriotomy when deployed at body temperature and when being releasedfrom the tube set.

For example, the primary material of a closure element and the like maybe of a NiTi alloy that forms superelastic nitinol. In the present case,nitinol materials may be trained to remember a certain shape, retainedwithin the tube set, and then deployed from the tube set so that thetines penetrate the tissue as it returns to its trained shape and closesthe opening. Also, additional materials may be added to the nitinoldepending on the desired characteristic. The alloy may be utilizedhaving linear elastic properties or non-linear elastic properties.

An SMP is a shape-shifting plastic that may be fashioned into a closureelement in accordance with the present disclosure. Also, it may bebeneficial to include at least one layer of an SMA and at least onelayer of an SMP to form a multilayered body; however, any appropriatecombination of materials may be used to form a multilayered device. Whenan SMP encounters a temperature above the lowest melting point of theindividual polymers, the blend makes a transition to a rubbery state.The elastic modulus may change more than two orders of magnitude acrossthe transition temperature (Ttr). As such, an SMP may be formed into adesired shape of an endoprosthesis by heating it above the Ttr, fixingthe SMP into the new shape, and cooling the material below Ttr. The SMPmay then be arranged into a temporary shape by force and then resume thememory shape once the force has been released. Examples of SMPs include,but are not limited to, biodegradable polymers, such asoligo(ε-caprolactone)diol, oligo(ρ-dioxanone)diol, and non-biodegradablepolymers such as, polynorborene, polyisoprene, styrene butadiene,polyurethane-based materials, vinyl acetate-polyester-based compounds,and others yet to be determined. As such, any SMP may be used inaccordance with the present disclosure.

The closure element, the delivery sheath, and the like may have at leastone layer made of an SMM or suitable superelastic material and othersuitable layers may be compressed or restrained in its deliveryconfiguration within the garage tube or inner lumen, and then deployedinto the tissue so that it transforms to the trained shape. For example,the closure element may be set in a trained shape that has a relativesmall diameter. The closure element can then be expanded and moved intoengagement with a body lumen wall adjacent a puncture. The closureelement can then be allowed to return to the trained state to close thepuncture.

Also, a closure element, the delivery sheath or other aspects orcomponents of the closure system may be comprised of a variety of knownsuitable deformable materials, including stainless steel, silver,platinum, tantalum, palladium, nickel, titanium, nitinol, havingtertiary materials (U.S. 2005/0038500, which is incorporated herein byreference, in its entirety), niobium-tantalum alloy optionally dopedwith a tertiary material (U.S. 2004/0158309, 2007/0276488, and2008/0312740, which are each incorporated herein by reference, in theirentireties) cobalt-chromium alloys, or other known biocompatiblematerials. Such biocompatible materials may include a suitablebiocompatible polymer in addition to or in place of a suitable metal.

In one embodiment, the closure element, the delivery sheath, and thelike may be made from a superelastic alloy such as nickel-titanium ornitinol, and includes a ternary element selected from the group ofchemical elements consisting of iridium, platinum, gold, rhenium,tungsten, palladium, rhodium, tantalum, silver, ruthenium, or hafnium.The added ternary element improves the radiopacity of the nitinol.

In one embodiment, the closure element, the delivery sheath, and thelike may be made at least in part of a high strength, low modulus metalalloy comprising Niobium, Tantalum, and at least one element selectedfrom the group consisting of Zirconium, Tungsten, and Molybdenum.

In further embodiments, the closure element, the delivery sheath, andthe like may be made from or be coated with a biocompatible polymer.Examples of such biocompatible polymeric materials may includehydrophilic polymer, hydrophobic polymer biodegradable polymers,bioabsorbable polymers, and monomers thereof. Examples of such polymersmay include nylons, poly(alpha-hydroxy esters), polylactic acids,polylactides, poly-L-lactide, poly-DL-lactide,poly-L-lactide-co-DL-lactide, polyglycolic acids, polyglycolide,polylactic-co-glycolic acids, polyglycolide-co-lactide,polyglycolide-co-DL-lactide, polyglycolide-co-L-lactide, polyanhydrides,polyanhydride-co-imides, polyesters, polyorthoesters, polycaprolactones,polyesters, polyanydrides, polyphosphazenes, polyester amides, polyesterurethanes, polycarbonates, polytrimethylene carbonates,polyglycolide-co-trimethylene carbonates, poly(PBA-carbonates),polyfumarates, polypropylene fumarate, poly(p-dioxanone),polyhydroxyalkanoates, polyamino acids, poly-L-tyrosines,poly(beta-hydroxybutyrate), polyhydroxybutyrate-hydroxyvaleric acids,polyethylenes, polypropylenes, polyaliphatics, polyvinylalcohols,polyvinylacetates, hydrophobic/hydrophilic copolymers, alkylvinylalcoholcopolymers, ethylenevinylalcohol copolymers (EVAL),propylenevinylalcohol copolymers, polyvinylpyrrolidone (PVP),combinations thereof, polymers having monomers thereof, or the like.

The present disclosure may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the disclosure is, therefore,indicated by the appended claims rather than by the foregoingdescription. All changes which come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

1. An anchor for using a closure device, the anchor comprising: a bodybeing configured to move from a pre-deployed state to a deployed state,wherein in the pre-deployed state the body has a first width aspectrelative to a direction of deployment and a second width aspect in thedeployed state relative to the direction of deployment, the second widthaspect being greater than the first width aspect and wherein the body isformed from a rapidly eroding material configured to erode throughdissolution within a body lumen.
 2. The anchor of claim 1, wherein thebody is configured to erode in less than twelve hours.
 3. The anchor ofclaim 1, wherein the body is configured to erode in less than one hour.4. The anchor of claim 1, wherein the body includes a major axis andwherein the body is configured to rotate in response to a force appliedparallel to the major axis.
 5. The anchor of claim 1, wherein therapidly eroding material includes at least one of a sugar and asugar-derivative.
 6. The anchor of claim 5, wherein the sugar derivativeincludes sugar alcohols including mannitol, sorbitol, and isomalt. 7.The anchor of claim 5, wherein the sugar includes at least one of agroup including glucose, fructose, lactose and maltose.
 8. The anchor ofclaim 1, wherein the body further includes at least one polymericcomponent.
 9. The anchor of claim 8, wherein the polymeric componentincludes at least one of poly-vinylpyrrolidone, poly-ethyleneglycol,hydroxyethyl starch, dextran or dextran sulfate.
 10. The anchor of claim1, wherein the rapidly eroding material is water soluble.
 11. The anchorof claim 1, wherein the rapidly eroding material forms a crystallinematrix.
 12. The anchor of claim 1, wherein the rapidly eroding materialforms a glass structure.
 13. The anchor of claim 1, wherein the rapidlyeroding material includes a plurality of pores.
 14. The anchor of claim13, wherein at least one of the pores includes at least one beneficialagent.
 15. The anchor of claim 13, wherein the anchor member includes atleast one of poly-vinyl pyrrolidone, hyaluronic acid, dextran, hydrogel,heparin, and benzalkonium heparin.
 16. The closure device of claim 1,wherein the anchor member is formed using a freeze-drying process.
 17. Amethod of closing a puncture in a wall of a body lumen, comprising:advancing an anchor in a deployment direction through the anchor, theanchor having a first width aspect relative to the deployment direction;deploying the anchor distally of the wall of the body lumen to cause theanchor to move to have a second width aspect relative to the deploymentdirection, the second width aspect being larger than the first widthaspect; drawing the anchor distally into engagement with a distal sideof the wall of the body lumen; and deploying a closure element into thewall of the body lumen, wherein the anchor is formed from a rapidlyeroding material that dissolves in the body lumen in less than twelvehours.
 18. The method of claim 17, wherein rapidly eroding materialdissolves in the body lumen in less than one hour.
 19. The method ofclaim 17, wherein deploying a closure element includes deploying anexpandable plug.
 20. The method of claim 17, wherein deploying a closureelement includes deploying tines into the wall of the body lumen.
 21. Aclosure device system comprising: a delivery sheath; a rapidly erodinganchor at least partially disposed within the delivery sheath in aninitial configuration, the closure member comprising one or more sugars;a suture element coupled to the closure member and disposed at leastpartially through the delivery sheath; and a pusher disposed at leastpartially within the delivery sheath and configured to deploy the anchormember from a distal end of the delivery sheath.
 22. The closure devicesystem of claim 21, further comprising an expandable plug configured tobe positioned between the anchor and the pusher.
 23. The closure devicesystem of claim 21, further comprising an expandable closure elementconfigured to be moved between an expanded state and a restricted stateto close a puncture in a wall of a body lumen.